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AnalyST Treadmill Study

This study has been completed.
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00949000
First received: July 29, 2009
Last updated: February 22, 2011
Last verified: February 2011
History of Changes
  Purpose

The objective of the study is to collect information on the naturally occurring variations in ST deviations at different heart rates, as detected by the AnalyST and AnalyST Accel Implantable Cardioverter Defibrillators (ICD).


Condition Intervention
Ischemic Heart Disease
 Device: ICD Implantation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of ST Segment Deviation Detection by SJM AnalyST and Analyst Accel Implantable Cardiac Defibrillators

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Evaluation of start and duration of isoelectric PR intervals [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Evaluation of start and duration of ST intervals [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Evaluation of ST segment deviations during stress testing across the 4 heart rate zones defined by the device [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Incidence of ischemic events detected based on the external ECG [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: July 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ICD Implant
Implantation of a commercially available AnalyST or AnalyST Accel ICD
 Device: ICD Implantation
Implantation of a commercially available AnalyST or AnalyST Accel ICD

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has received or is scheduled to receive a St Jude Medical AnalyST or AnalyST Accel ICD;
  • Patient has documented ischemic heart disease.

Exclusion Criteria:

  • Patient has an indication for ventricular pacing;
  • Patient has chronotropic incompetence or insufficiency;
  • Patient has a contraindication to stress testing;
  • Patient is physically unable to complete the stress test protocol;
  • The patient has persistent or permanent atrial fibrillation (AF);
  • Patient is unable to comply with the protocol and follow-up schedule based on geographic location or for any reason;
  • Patient is pregnant;
  • Patient is minor (< 18 years old).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949000

Locations
Germany
Klinikum Coburg
Coburg, Bavaria, Germany, 96450
Kerckhoff-Klinik
Bad Nauheim, Hesse, Germany, 61321
Medizinische Einrichtungen der RWTH Aachen
Aachen, N. Rhin, Germany, 52074
Klinikum der Stadt Ludwigshafen am Rhein
Ludwigshafen, N. Rhin, Germany, 67063
Klinikum Luedenscheid
Luedenscheid, N. Rhin, Germany, 58515
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Christian Hamm, Prof. Dr. Kerckhoff-Klinik, Bad Nauheim, Germany
  More Information

No publications provided

Responsible Party: Prof. Dr. Christian Hamm, Kerckhoff-Klinik
ClinicalTrials.gov Identifier: NCT00949000     History of Changes
Other Study ID Numbers: CR08018HV
Study First Received: July 29, 2009
Last Updated: February 22, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Coronary Disease
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013